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临床试验/NCT04007952
NCT04007952已完成不适用

Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair

Clayton Petro2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Clayton Petro
入组人数
240
试验地点
2
主要终点
Paraesophageal Hernia Recurrence

研究概览

简要总结

This study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. Half of participants will receive anterior gastropexy, while the other half will not. The hypothesis is that anterior gastropexy will help to prevent paraesophageal hernias from recurring.

详细描述

Paraesophageal hernias are hernias in which the stomach and/or other abdominal organs herniate through the diaphragm into the chest. This abnormal anatomy can lead to acid reflux, trouble swallowing, and shortness of breath, and can also be a risk factor for surgical emergencies involving the stomach. For these reasons, the Society of American Gastrointestinal and Endoscopic Surgeons has strongly recommended that all symptomatic paraesophageal hernias be repaired.

These repairs are technically challenging, and the best available evidence suggests that more than half of patients undergoing repair will have radiographic hernia recurrence at 5 years after surgery. There has been suggestion that use of anterior gastropexy - in which suture is used to affix the stomach to the anterior abdomen - may reduce recurrence rates. However, it is uncertain whether this data is reliable. While some surgeons use anterior gastropexy routinely because they believe it reduces recurrence, other surgeons do not use anterior gastropexy due to the concern that patients will have short-term pain at the suture site. This study aims to evaluate the effect of using anterior gastropexy on recurrence rates after paraesophageal hernia repair, compared to not using anterior gastropexy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not be informed regarding the treatment that they received until they complete 1-year follow-up. Imaging will be reviewed at the end of the study period by surgeons who are blinded to treatment group.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to participate in follow-up
  • Symptomatic paraesophageal hernia
  • Paraesophageal hernia is at least 5 centimeters in height on upper GI study or endoscopy
  • Elective laparoscopic paraesophageal hernia repair (must begin laparoscopic, but may convert to open surgery if needed)
  • Crura must be reapproximated at time of surgery

排除标准

  • Previous operations of the esophagus or stomach
  • Emergent operation for acute gastric volvulus
  • Paraesophageal hernia repair with concurrent bariatric procedure or procedure to reduce stomach volume
  • Placement of gastrostomy tube

结局指标

主要结局

Paraesophageal Hernia Recurrence

时间窗: 1 year

Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence

次要结局

  • Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year(30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months))
  • Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year(30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months))

研究者

发起方
Clayton Petro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Clayton Petro

Assistant Professor

The Cleveland Clinic

研究点 (2)

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